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PerkinElmer Coronavirus Assay Gets FDA Emergency Use Authorization

2020/3/30 14:31:41 Views£º556

New York ¨C PerkinElmer said after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the firm's coronavirus RT-PCR test.

CLIA-certified labs can immediately use the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which detects the SARS-CoV-2 coronavirus that causes COVID-19.

The assay recently received CE-IVD marking and can detect the coronavirus in oropharyngeal swab, nasopharyngeal swab, bronchoalveolar lavage, sputum, plasma, or serum samples. It detects SARS-CoV-2 ORF1a and N genes and has a limit of detection of 20 copies per mL using a 400 ¦ÌL sample, the Waltham, Massachusetts-based firm said on its website.


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